Consent forms in Brazil: analysis of quality and legibility

Abstract

The emergence of the informed consent form is a paradigmatic transition mark that leads doctors and patients to a more balanced and less paternalistic relationship. The objective of the study was to evaluate the quality and adequacy of the consent form to the ethical precepts inherent to the relationship established between doctors and patients. In this sense, the information provided to the patient becomes undeniably relevant, and registration is a necessity. The present study evaluated the quality and adequacy of the consent form regarding the information process necessary to make decisions. Consent Forms were collected from Brazilian medical societies and hospitals and submitted to the Flesch-Kincaid test to measure the legibility of texts and other essential items. 110 consent forms were analyzed, evaluating parameters that influence the patient's complete understanding. In the analyzed criteria, most of the forms identified the type of procedure to be performed (n=88), described the complications (n=93), required the joint signature of the doctor and the patient (n=61), and displayed adequate fonts and sizes (n=84). Meanwhile the minority presented information about the place where the procedure was performed (n=19), the description of the procedure (n=29), and the patient's right to refuse (n=10). From the analysis by the Flesch-Kincaid readability index, it was demonstrated that most of the terms analyzed presented a moderately difficult reading level (n=71), followed by a difficult reading level (n=27). Data analysis reveals texts that are difficult to understand and have serious flaws in their elaboration, not only in their readability, but also in their structure.

Keywords

• informed consent, patient safety, doctor-patient relationship, medical ethics, reading